Access to cheap and good medicines in jeopardy?

Globalisation has changed the way businesses act and make their profits. Currently much of the profits generated by industry and services come from the copyrighting of inventions, etc. through “intellectual property” (IP) laws. This has implications for access to technology, information and products such as medicines and seeds.


Intellectual property regulation has become the new way rich countries “keep control” of the countries of the Global South. These strict regulations also impact on the health services in developing countries.


The so called TRIPS agreement on Intellectual Property Rights negotiated in 1994 required all World Trade Organisation (WTO) members to establish patent protection in their countries by 2005. This was seen as a constraint for public health in low- and middle-income countries. These IP regulations resulted in decreased access to medicines in many developing countries, as it became impossible for them to produce or buy cheap replicas of medicines protected by patents.  In response to complaints from civil society and the countries affected, the WTO adopted the Doha Declaration in 2001 which allowed developing countries to break patents during public health emergencies by declaring “compulsory licenses[1]”.  By doing so, they could produce or import generic drugs. 


In developing countries generic medicines play an important role in raising public health standards. Today generics of good quality are cheap, on average a third of the branded price. Strict IP rules uphold patents and so keep prices high, while restricting and delaying generic competition in Africa, thereby damaging health provision there.


Western countries tend to impose stricter IP regulations as the years go by. The instruments used are the Free Trade Agreements with the countries of the South. Conflicts between protectors of IP law and defenders of public health have intensified lately. On one side we find the big pharmaceutical companies, the World Trade Organization (WTO), the USA and the EU, and on the other civil society and health-care institutions. The clashes of these two groups are mainly over access to medicines in developing countries. The debate centres on the value and role of patents for pharmaceutical products and their negative impact on the protection of public health.


Despite its shortcomings the TRIPS agreement recognises the public health needs of countries, and allows for flexibility. But in its later Trade Agreements, such as the Economic Partnership Agreements (EPA) with the African Caribbean and Pacific Countries (ACP), the EU adds provisions on IP that go beyond the demands of the WTO.  Patents are valid for more than 20 years and the granting of compulsory licenses is restricted thus delaying the entry of generics on the African market. The EU rules secure and extend monopolies for brand name pharmaceuticals, allowing companies to charge monopoly prices and reap huge revenues. These commercial benefits are gained at the expense of health provision in Africa. Because competition from cheaper generic equivalents is thwarted, the cost of drugs rises and this inhibits access to essential medicines.  Such is the effect of strict IP rules.


Although the European Commission says that the Cariforum-EPA (the only region to have signed a final EPA) promotes the TRIPS flexibility regarding access to medicines, there are fears that strong IP regulation will be imposed during the EPA negotiations with the African regions. 


In its relations with developing countries, the EU takes with one hand what it gives with the other. While the EU’s Development policy has a strong commitment to improving public health, the imposition of IP Rights in the trade agreements it will sign with the ACP countries undermines this. Moreover, the IP rules that the EU tries to impose on the African regions are not in line with European Parliament resolutions and EU commitments in the area of Access to Medicines.


Another current danger for access to cheap medicines is the new treaty known as the “Anti-Counterfeiting Trade Agreement (ACTA)” that is being negotiated among the rich countries including USA, EU, Japan, Canada, Australia.  ACTA is part of a broader strategy employed by countries supporting rigid IP rights enforcement. It is certain to undermine access to low-cost generic medicines, treating them as counterfeit goods. The recent seizure of generic medicines by the Dutch customs illustrates this fear.  The medicines that were in transit in the Netherlands (going from India to Brazil in one case and from India to Nigeria in another) were of “good quality”.  While officials claimed the drugs were counterfeits and violated patent rules, UNITAID[2], the Geneva-based agency which paid for the medicines, demanded their release saying the claims were mistaken.


Civil society in Africa, as in the whole world, has a role to play to prevent these threats from becoming a reality. The Trade agreements (EPAs) should be coherent with the EU Public Health policy for developing countries.  The agreements should emphasise that IP enforcement measures should not divert resources away from other priority areas such as health.  In the EPAs, the EU should prioritise its commitment to support development over the pursuit of stringent IP regulations.    

                                                                                                                                                                                                                                                                                     Begoña Iñarra


[1] Compulsory Licensing is the granting of a license to another producer to manufacture, use, and distribute generic versions of patented inventions without the consent of the patent holder in exchange for remuneration to compensate for the reduction of the potential market for the branded sale of the drugs.

[2] UNITAID is supported by international donor governments - including several EU nations such asFrance and theUK .

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